Valve and a method for administering a plurality of drug fluids

ABSTRACT

A valve and a method for administering a plurality of drug fluids to a patient are disclosed. For each drug fluid, the valve may be rotated into a selected drug position associated with the drug fluid. With the valve being in the selected drug position, a backpriming may be performed of a connector line of a drug container containing the drug fluid. Thereafter, the drug fluid may be administered with the valve being in the same selected drug position. Thereafter, the valve may be flushed, optionally while maintaining the same selected valve position.

TECHNICAL FIELD

The present invention relates to administration of drug fluids. Morespecifically, the invention relates to a valve and a method forsequential administration of a plurality of drug fluids to a patient,such as cytostatics, antibiotics, nutritions and electrolytes.

BACKGROUND

Present Multi-Drug Intravenous Therapy Systems

FIG. 12 schematically illustrates an intravenous (IV) therapy system 10typically used in the U.S. and FIG. 13 schematically illustrates an IVtherapy system 10′ typically used in Europe. Where appropriate, the samereference numerals are used in FIGS. 12 and 13 to designate similarcomponents.

Both IV systems 10 and 10′ are designed for administering a neutralfluid A, such as a saline fluid, and two or more different drug fluids Band C to a patient. Each system 10, 10′ comprises three interconnectedIV infusion sets, each IV infusion set including at least a pre-filled,sterile container, a sterile connector tube or line, a clamp or a valveto regulate or stop the flow, and a connector, such as a Luer connector,at the end of the connector line.

In the field of IV infusion where both a neutral fluid, such as a salinefluid, and one or more drug fluids are to be administered to a patient,the terminology normally used in the art is that the infusion of theneutral fluid is referred to as the “primary infusion” or “main line”,whereas the infusion of a drug fluid is referred to as the “secondaryinfusion” or “secondary line”. This terminology will be used in thepresent application. However, for the sake of clarity and explanation inthe present application, where appropriate the more descriptive terms“saline” or “flushing” and “drug” will be used as equivalents to“primary” and “secondary”, respectively. The term “downstream” refers toa direction towards the patient, whereas the term “upstream” refers to adirection opposite to downstream.

An IV infusion set may also include a drip chamber which captures anyair bubbles occurring in the IV infusion set.

Using the above terminology, the U.S. system 10 in FIG. 12 comprises aprimary or main IV set 16, a first drug IV set 16B and a second drug IVset 16C. The main IV set 16 includes a saline container 12A containing aneutral fluid A, such as saline, a drip chamber 14A normally locatedadjacent the saline container 12A on the main IV line upper part 16A anda saline back check valve 17A on the main IV line upper part 16A. Thefirst and second drug IV sets 16B and 16C include first and second drugcontainers 12B and 12C, respectively, first and second drug dripchambers 14B and 14C, respectively, and first and second drug clampsthat normally is either a slide clamp, pinch clamp or roller-clamp, 18Band 18C, respectively. The first and second drug IV sets are connectedto the main IV line 16 via Y-ports 20B and 20C, respectively. The mainIV line 16 is connected to the patient, optionally via an infusion pump30 to control the infusion flow rate, or via gravity only where theinfusion rate is controlled by e.g. a roller clamp 18A.

The European infusion system 10′ in FIG. 13 presents at least thefollowing differences in relation to the U.S. system 10 in FIG. 12:

In the European system 10′, the first and the second drug IV sets haveno drip chamber of their own but are instead connected to the main IVline 16 upstream (above) the main drip chamber 14A, which therebyoperates as a common drip chamber for the whole system 10′.

In the European system 10′, each one of the first and the second drug IVsets 16B, 16C also includes a back check valve 17B and 17C,respectively.

In the European system 10′, the upper part 16A of the main IV line 16includes a clamp 18A used to open and close the flow from the salinecontainer 12A.

The U.S. system 10, when administering e.g. the first drug B, has anopen flow line on both the primary line 16A, and secondary line 16B, andtherefore relies on hydrostatic pressure difference between the primaryand secondary infusion containers to obtain the infusion sequence, wherethe secondary infusion gets infused first due to higher pressure, whilestopping the primary infusion with back pressure. After the secondaryinfusion has run empty, the back pressure on the primary infusionreleases and allows the primary infusion to run. In contrast, in theEuropean system all infusion containers normally hanging on about thesame level with no or very little hydrostatic pressure difference, andthe primary infusion needs to be closed with a clamp 18A while thesecondary infusion runs.

When using the systems 10 and 10′, priming of the main IV line 16A isnormally done by squeezing the main drip chamber 14A to fill it abouthalfway, and then opening the clamp or clamps on the main line to let hesaline flow though the main IV line 16A out through the initially freeend of the tubing. Since this main IV line 16A normally contains neutralsaline this method may be considered to be safe. Once the main IV line16A has been primed, it may be connected to the patient with a connectorthat may be of Luer type

In U.S. system 10, a drug IV set is delivered with the drug line beinginitially empty. Before connecting a secondary line to the main IV line16, the secondary line should be primed to avoid air bubbles in thesystem. There are mainly two different methods used: priming thesecondary line before the secondary fluid or drug fluid is connected tothe main line, or backpriming the secondary line after it has beenconnected to the main IV line.

The first method, priming out of the free end, is performed as follows:the drug lines 16B and 16C may be primed in the same manner as with themain IV line 16A, which would involve letting the drug fluid flowdownstream from the drug container B, C, and out from the free tubingend before the drug line is connected to the main IV line 16. However,when the secondary fluid is a drug, this method may be considered to beless safe.

The second method, backpriming, is performed as follows and is possiblythe safest method of the two: the user connects one end of the initiallyempty secondary line 16B, 16C to the drug container 12B, 12C by spikingthe drug container and holding the latter upside down in order to avoidspillage. Once connected, the other (downstream) end of the drug line isconnected to the main IV line 16. Thereafter, a so-called backpriming ofthe drug line is performed. The backpriming of the drug line is achievedby holding the drug container at a level with lower hydrostatic pressurethan the saline container 12A, then opening the clamp 18B, 18C on thedrug line and then letting the saline fluid backprime (fill) the drugline. Since the drug line in the U.S. system 10 normally has a dripchamber 14B, 14C, this drip chamber will now start to fill up and thefilling thereof should be stopped when it is half full by closing theclamp 18B, 18C or by holding the drug container at a higher level thanthe saline container.

In contrast to the U.S. system, in the European system 10′ in FIG. 13 adrug IV set is normally delivered from the pharmacy with the drug line(16B, 16C) being pre-primed with saline and with a clamp (18B, 18C)fitted to the drug line. The drug line is usually not filled all up tothe very end, so this may require a priming sequence similar to the U.S.system allowing fluid escape out of the free end, but this is safer thanthe first method explained in the U.S system since a possible firstspillage would be the prefilled saline. Since connecting the secondaryline, even if it is pre-primed, may involve a risk of an air bubblebeing trapped when the line is connected to the main IV line 16A, themain drip chamber 14A in this system 10′ is arranged downstream the Yports 20B, 20C in order to capture any potential air bubble.

When performing an infusion using the systems 10 and 10′ describedabove, the normal infusion sequence would be as follows:

To verify that the system is set up correctly, the primary or salinefluid flow is first opened by opening the clamp on the main IV line 16.Then the nurse may verify that the fluid flows by noticing that there isdripping in the drip chamber and there is no bulge formed on the patientat the infusion site and no leakage, and by verifying that the IV setfunctions properly and is correctly connected to the patient's vein orother checks governed by local protocols. The basic, first function ofthe first saline is to prepare the patient for receiving infusion and toverify that the infusion functions properly.

Next, a first drug fluid will be administered and the associated drugcontainer is normally emptied before the saline is again opened to flushthe main IV line from drug residuals and to dilute the previous drugfluid into the vascular system of the patient. Thereafter, a subsequent,second drug fluid will be administered.

Finally, after all drug fluids have been administered, the saline isagain used to dilute the drug into the patient's vascular system beforeending the treatment.

Infusion pumps may be used to have a better control over the infusionflow rates instead of verifying the infusion flow rate by counting thedrip rate in the drip chamber. An infusion pump may also be used forother safety purposes, such as generating an alarm if an air bubbleoccurs in the system or if the system runs empty.

There are plenty of medical situations in which a multiple of drugfluids to be administered into a patient has to be handled. Inchemotherapy it is often of utmost importance to handle drug fluids to apatient which is treated for cancer in a reliable and safe manner.However, due to stressful working environments, tiredness, the humanfactor, etc., the handling of these drug fluids, including theirconnections, dosages, priming of infusion lines, etc. may lead toerrors. For example, there is a need to clearly separate differentfluids from each other, since they may chemically react in an undesiredmanner.

Applicant's WO 2013/055278 discloses a multiple-drug valve foradministration of a plurality of drug fluids, such as cytostatics. Thisprior-art multiple-drug valve comprises a housing having a plurality ofcircumferentially distributed primary inlets for receiving a respectiveone of the drug fluids and a secondary inlet for receiving a secondaryfluid, such as a neutral fluid. The valve has an outlet from which thefluids will be directed to the patient. A rotary valve member isarranged in the housing. The housing has a plurality of primary valvepositions in each of which an associated one of the primary inlets isconnected to the outlet, and a plurality of intermediary valve positionsin each of which the secondary inlet is connected to the outlet.Moreover, the valve member has an outer surface sealingly engaging aninner surface of the housing, such that the primary and secondary inletsare sealingly connected to openings arranged in the outer surface of thevalve member in each of the primary and intermediary valve positions,respectively.

Parallel infusion of incompatible drugs is generally not allowed, nortemporary mixing of incompatible drug fluids due to drug fluid residualsin the rotatable valve member.

SUMMARY OF THE INVENTION

An object of the invention is to provide a valve and a method for use inperforming a sequential administering of a plurality of drug fluids.

The inventive valve makes it possible to perform backpriming ofnon-primed drug lines, each of which is connected to an associatedcontainer containing a respective one of the drug fluids to beadministered, said backpriming being performed before the drug fluidsare administered to a patient via the valve.

The inventive valve makes it possible to perform a complete flushing ofthe valve after administering a drug fluid and before administeringanother drug fluid, thereby eliminating or at least substantiallyreducing the risk of drug incompatibility within the valve.

The inventive valve makes it possible to perform, for each one of aplurality of drug fluids, a backpriming, a drug administering and aflushing by using the same valve for all the drug fluids and by usingone and the same selected valve rotational position for each one of thedrug fluids, and all this with a high degree of security when shiftingfrom one drug fluid to a subsequent drug fluid, eliminating or at leastsubstantially reducing the risk of drug incompatibility within thevalve.

According to the inventive concept, there is provided a valve foradministering two or more drug fluids, comprising:

a rotational axis,

a housing having:

-   -   an inner cavity    -   an inner circumferential surface,    -   one flushing inlet for receiving a flushing fluid, the flushing        inlet being fluidly connected to a flushing outlet, which opens        into the inner cavity and is positioned on a first level with        respect to the rotational axis, and    -   a plurality of drug inlets, each drug inlet for receiving an        associated drug fluid and each drug inlet being fluidly        connected to an associated drug outlet opening into the inner        cavity and being positioned on a second level that is different        from the first level; and

a valve member having:

-   -   an outer circumferential surface, and    -   a main passageway presenting an inlet arranged in the outer        circumferential surface at the second level and an outlet        arranged coaxially with the rotational axis;

wherein the valve member is arranged to be rotated into any selected oneof a plurality of drug positions, each drug position being associatedwith a respective one of said drug outlets; and

wherein, in each selected drug position, the drug outlet which isassociated with the selected drug position is fluidly connected to boththe inlet of the main passageway and to the flushing outlet.

According to the inventive concept, there is also provided a valve foradministering two or more drug fluids comprising:

an outlet,

a rotational axis,

a housing having:

-   -   an inner cavity    -   an inner circumferential surface,    -   one flushing inlet for receiving a flushing fluid, the flushing        inlet being fluidly connected to a flushing outlet, which opens        into the inner cavity and is positioned on a first level with        respect to the rotational axis, and    -   a plurality of drug inlets, each drug inlet for receiving an        associated drug fluid and each drug inlet being fluidly        connected to an associated drug outlet opening into the inner        cavity and being positioned on a second level that is different        from the first level; and

a valve member having:

-   -   an outer circumferential surface, and    -   a main passageway presenting an inlet arranged in the outer        circumferential surface at the second level and an outlet        arranged coaxially with the rotational axis;

wherein the valve member is arranged to be rotated into any selected oneof a plurality of drug positions, each drug position being associatedwith a respective one of said drug outlets; and

wherein the valve presents, in each selected drug position:

-   -   a drug flow path extending from the associated drug outlet,        through the main passageway, and to the outlet of the valve,    -   flushing flow path extending from the flushing outlet to the        outlet of the valve and comprising a first part not being common        with the drug flow path and a second part being common with the        drug flow path, and    -   a backpriming flow path extending from the flushing outlet to        the associated drug outlet and being at least partly common with        the first part of the flushing flow path.

According to the inventive concept, there is further provided a methodfor administering a plurality of drug fluids to a patient using aflushing container containing a flushing fluid, a plurality of drugcontainers each containing an associated drug fluid and being providedwith an associated drug connector line, a valve having valve memberwhich is arranged to be rotated into a plurality of drug positions, eachdrug position for administering an associated drug fluid, and a primaryIV line connected to a patient, said method comprising, for each drugfluid of said plurality of drug fluids:

-   -   rotating the valve member into a selected drug position        associated with the drug fluid;    -   with the valve being in the selected drug position, backpriming        a connector line of a drug container containing the drug fluid        by providing a flow of the flushing fluid from the flushing        container via the valve and into the secondary connector line;    -   thereafter, and with the valve being in the selected drug        position, administering the drug fluid by providing a flow of        the drug fluid from the drug container containing the drug fluid        via the valve to the primary IV line; and    -   thereafter flushing the valve by providing a flow of the        flushing fluid from the flushing container via the valve to the        main IV line.

Preferred embodiments of the valve and the method are set out in thedependent claims.

The valve and the method of the present invention are especially, butnot exclusively, useful for performing a multi-drug administeringaccording to procedures being used in the U.S. where initiallynon-primed secondary lines are backprimed before the secondary infusionsare initiated. More specifically, the valve of the present inventionmakes it possible for a user to perform, with the valve member beingpositioned in a selected drug position for a selected one of a pluralityof drug fluids, both the backpriming of the drug line associated withthe selected drug fluid and the administering of the selected drugfluid.

The valve and the method of the present invention are also useful forperforming a multi-drug administering according to procedures presentlyused in other countries, such as in Europe.

As a further advantage, the inventive valve allows a user to alsoperform a third step of the infusion process—the flushing of the valveand the main IV line after the administering of one drug has beenfinished—with the valve member being positioned in the same selecteddrug position as used during backpriming and drug administering.

Since the valve may be positioned in the same drug position whenperforming all three actions, the valve presents the advantage that therequired number of valve operations may be kept to a minimum and alsothe advantage that a handle of the rotary valve member may be positionedvisually aligned with a selected drug inlet for each associated drugfluid during the three steps. The user may thus easily associate eachselected valve position with the drug fluid presently being handled,further increasing the overall safety aspect of the procedure.

The inventive valve allows multiple secondary lines to be connected tothe valve and allows multiple drug fluids to be administered to thepatient, one at a time, without the risk of unintentionally mixingincompatible drug fluids, by using a turn valve configuration wherethere is no connection between two drug inlets, which also leads to thebenefit that back flow valves on the secondary lines become redundant.This is a cost saving for the European system and an additional safetybenefit for the U.S. system where backflow valves have been impossibleto use, because of the need to back prime the secondary lines.

The inventive valve allows multiple secondary lines to be connected tothe valve and allows multiple drug fluids to be administered to thepatient, one at a time, without the risk of unintentionally mixing ofincompatible drug fluids. The secondary lines do not need to be re-used,but rather a new secondary line is connected to a new drug inlet foreach drug fluid. This advantage will reduce the risk of any drugincompatibility of drug residuals within the same secondary line, ifthis is re-used and re-spiked with a different drug fluid. The risk ofre-spiking bags may involve a risk of contamination that may lead tobacteria colonization and could lead to catheter related blood streaminfection for the patient, but also the healthcare worker is at higherrisk for toxic fumes or spillage.

The inventive valve allows all secondary lines to be connected beforepatient has arrived, and even the infusion system may be prepared, andall secondary lines to be connected to the valve, in a different room ina sterile environment with good ventilation before use, to increasesafety for both patient and healthcare workers.

The valve may preferably be structured and arranged such that differentdrug fluids never will mix in the valve. Thus, in a preferred embodimentit is not possible to rotate the valve member into a position wheredifferent drug inlets of the valve are in fluid contact with each othervia the valve.

The inventive valve is structured and arranged in such a way that, ineach selected drug position of the valve member, a drug outlet which isassociated with the selected drug position is fluidly connected to boththe inlet of the main passageway of the rotary valve member and also tothe flushing outlet in the housing. This means that in each selecteddrug position, there is a fluid connection between all three of theassociated drug outlet, the main passageway of the valve member and theflushing outlet of the housing. Because of this intended “openstructure” of the inventive valve in each selected drug position—whichstructure allows the user to perform up to three actions for eachselected drug fluid with the valve member being positioned in one andthe same drug position associated with the selected drug fluid—in orderto ensure that a correct fluid (drug fluid or saline fluid) will flowthrough the valve in each selected drug position, some additional fluidcontrol may be required to ensure that either the drug fluid flowsthrough the valve (during drug administering) or the saline fluid flowsthrough the valve (during backpriming and during flushing).

In some embodiment, such an additional fluid control may be implementedby arranging the saline container on the one hand, and each drugcontainer on the other hand, on different levels in order to create aflow controlling pressure difference. Thus, during drug administeringthe associated drug container may be held on a higher level than thesaline container, and during backpriming and flushing the salinecontainer may be held on a higher level than the drug containers. In analternative embodiment, such an additional fluid control may beimplemented by arranging clamps and/or back check valves on the fluidlines. These embodiments may be combined.

In some embodiments, the valve may further comprise a distributionchannel which is arranged to carry the flushing fluid and which isformed at an interface between the housing and the valve member, saiddistribution channel being circumferentially oriented in relation to therotational axis and fluidly connected to the flushing outlet. Thepurpose of the distribution channel is to make it possible to haveaccess to the flushing fluid in each selected drug position of theplurality of drug positions, even if the valve comprises one flushinginlet only. The surfaces defining the circumferentially orienteddistribution channel may be formed in combination by one or moresurfaces of the housing and one or more surfaces of the valve member. Ina preferred embodiment, the distribution channel is formed when thevalve member is inserted into the housing cavity during assembly. Thedistribution channel may be arranged on the same first level as theflushing outlet such that the flushing outlet opens into thedistribution channel.

In order to carry the flushing fluid from the distribution channeltowards the respective drug outlets of the housing, the valve member mayfurther comprise a transfer channel for carrying the flushing fluid, thetransfer channel being fluidly connected to the distribution channel andextending at least partly in the direction of the rotational axistowards the second level. The transfer channel may extend in parallel tothe rotational axis or in an inclined orientation. The flushing fluidpresent in the distribution channel will be in fluid connection with thetransfer channel in each one of the drug positions of the valve member.When the valve member is rotated, the transfer channel will thus berotated together with the valve member.

There are different possibilities of completing the fluid transfer fromthe circumferential distribution channel to each one of the drugoutlets. This fluid transfer will be performed in a direction which isaxial, inclined or a combination thereof.

According to a first alternative embodiment for creating a flow pathbetween the flushing outlet to the drug outlets, an outlet of thetransfer channel of the valve member may be directly connected, withinthe valve member, to the main passageway between the inlet and theoutlet thereof. In this embodiment, the transfer channel may be formedby a bore in the valve member body or by an at least partly radiallyopen groove or recess which is formed in the circumferential outersurface of the valve member and which is closed by the innercircumferential surface of the housing to complete the shape of thetransfer channel. In this alternative, it may be preferred that theoutlet of the transfer channel connects to the main passageway in thevalve member close to the inlet of the passageway such that, whenperforming a flushing operation, the flushing fluid enters the mainpassageway from the transfer channel at the very beginning of the mainpassageway and, thereby, flushes the entire main passageway towards theoutlet thereof.

According to a second alternative embodiment for carrying the flushingfluid to the drug outlets, the housing may further comprise a pluralityof flushing recesses formed in the inner circumferential surface of thevalve housing, each flushing recess being associated with a selecteddrug position and extending at least partly in the direction of therotational axis and being fluidly connected to an associated drugoutlet. Each flushing recesses may be axially oriented and angularlyaligned with an associated drug opening. In each selected drug position,the drug outlet which is associated with the selected drug position maythen be in fluid connection with the flushing outlet via a flow pathformed by the distribution channel, the transfer channel and theflushing recess which is associated with the selected drug position.During backpriming, the flushing fluid may then flow, at the secondlevel, directly from a flushing recess and out through an associateddrug inlet without passing through any part of the main passageway ofthe valve member. During flushing, the flushing fluid may flow to thesecond level via a flushing groove and then enter the inlet of the mainpassageway from the drug opening which is presently being aligned withthe main passageway.

This embodiment may have the advantage to have a main channel inlet thatis closed off completely by sealingly engaging the valve house innersurface in an alternative valve position, resulting in a rotationalposition where no fluid can flow though the valve's outlet.

According to a third alternative embodiment for transferring theflushing fluid to the drug outlets, the transfer channel formed in thevalve member may have a first end, which is located on the first leveland is fluidly connected to the distribution channel, and a second end,which is located adjacent the second level and which together with theinlet of the main passageway, in each selected drug position, bifurcatesthe drug outlet associated with the selected drug position. Thebifurcation may extend in a direction perpendicular to the rotationalaxis such that, when viewed radially inwards from a drug outlet, onewould see both the outlet of the transfer channel on one axial side ofthe bifurcation and the inlet of the main passageway on an oppositeaxial side of the bifurcation. In each selected drug position, the drugoutlet which is associated with the selected drug position may then befluidly connected to the flushing outlet via a flow path formed by thedistribution channel and the transfer channel. When performing aflushing operation, the flow path would continue in a U turn at the drugopening around the bifurcation and then into the main passageway of thevalve member. This may be useful for priming of drug inlets before usewhen there is a cap fitted on the drug inlet, and or may be useful ifthe drug inlet is fitted with a closed system device such as anelastomeric element that is normally closed but opens when e.g. a maleluer tip is connected to the drug inlet.

In some embodiments, the distribution channel may extend in acircumferential direction over 365 degrees to form a complete annulardistribution channel. In some alternative embodiments, the distributionchannel may extend in a circumferential direction less than 365 degreesto form a partial annular distribution channel. The partly annulardistribution channel may present two ends, wherein one of the ends maypreferably be located at an angular position at which the distributionchannel connects to the transfer channel. Thereby, an internal primingof the valve's dead space is obtained before the valve is used, by theflushing fluid pushing any air bubbles present in the distributionchannel out of the distribution channel and into the transfer channel,and out of either a drug inlet or out of the valve's outlet before it isconnected to the patient, without any risk of an air bubble remaining inthe distribution channel, which is thereby primed for all subsequentvalve positions.

In some embodiments, the inner circumferential surface of the housingmay be in sealing engagement with the outer circumferential surface ofthe valve member. The inner circumferential surface of the housing andthe outer circumferential surface of the valve member may becylindrical, conical, frusto-conical or combinations thereof.

In some embodiments, the main passageway of the valve member maycomprise a first part extending from the inlet of the main passagewaytowards the rotational axis, and a second part extending coaxially withthe rotational axis, from an radially inner end of the first part of themain passageway, towards the outlet of the main passageway. The secondpart may also extend in a direction not being coaxial with therotational axis. In other embodiments, the main passageway may extend inany direction between the inlet and the outlet thereof. The outlet ofthe main passageway is preferably located coaxially with the rotationalaxis.

In some embodiments, the outlet of the main passageway of the valvemember may form the outlet of entire valve, i.e. the fluid would exitfrom the valve at the outlet of the main passageway without re-enteringthe housing, and in this case the passageway outlet does not need to beformed coaxially with the rotational axis. In some embodiments, theoutlet of the main passageway of the valve member may instead be fluidlyconnected to an outlet of the valve formed in the housing, and in thosecases the outlet is preferably formed coaxially with the rotational axisto avoid unnecessary dead space volume that would need flushing.

In some embodiments, the plurality of drug positions constitute the onlyrotary positions of the valve member allowing a drug to be administeredfrom a drug inlet to an outlet of the valve. In such embodiments, theonly rotary positions of the valve member in which a drug may flow froma drug inlet through the valve would be said plurality of drug positionsin which there is also a fluid connection from the flushing outlet tothe valve opening. In other words, there would be no “pure” drugpositions in which a drug outlet but not the flushing outlet is fluidlyconnected to the main passageway via the valve.

As to the first and second levels, these may be arranged according totwo alternatives. The valve member may typically be provided with ahandle for rotating the valve member. According to a first alternative,the first level is located closer to the handle than the second level.In a second alternative, the second level is located closer to thehandle than the first level.

In some embodiments, the valve member may be provided with a handle forrotating the valve member, wherein in each selected drug position thehandle may be aligned with a drug inlet associated with the selecteddrug position. An advantage is thereby achieved that a user may visuallyassociate a selected handle position with a drug presently beinghandled. As an example, when handling a first drug fluid, a user mayalign the handle with an associated first drug inlet of the valve duringthe backpriming of an associated first drug line, during theadministering of the first drug fluid and during flushing of the valvefor any residuals of the first drug fluid.

The inventive method for administering a plurality of drug fluids may beperformed according to various embodiments. In some embodiments, thesteps of rotating the valve into a selected drug position, backprimingan associated drug line with the flushing fluid, administering anassociated drug fluid and flushing the valve with the flushing fluid maybe performed as direct sequence, one step directly after the other,while maintaining the valve member in the selected drug position duringthe backpriming, the administering and the flushing. In some alternativeembodiments, the backpriming may be performed for two or more drugsinitially, in order to prepare the set-up or system for administering,such as in another room than the room where the patient located. In suchembodiments, one and the same selected valve position may be maintainedduring the subsequent drug fluid administering and flushing for eachdrug fluid.

In some embodiments, the valve member may further be arranged to berotated into any selected one of one or more flushing positions,wherein, in each selected flushing position, the inlet of the mainpassageway is fluidly connected to the flushing outlet but not to anyone of the drug outlets. In such embodiments, the flushing may beperformed either in the selected drug position (valve rotationalposition maintained) or in an intermediate “pure” flushing position inwhich no drug outlet is fluidly connected to the outlet of the valve. Ifthe valve comprises two drug inlets only, only one single flushingposition may be needed in such embodiments.

In some embodiments, the valve member may further be arranged to berotated into any selected one of one or more closed positions, whereineach closed position there is no fluid connection between the druginlets and the valve outlet, nor any fluid connection between theflushing inlet and the valve outlet.

The different valve positions are preferably predetermined positions andare preferably identifiable by the user. This may be done by the shapeof a handle and/or by arranging a tactile or haptic response to a userat each valve position so the operator can sense the correct position(“click indication”).

The valve is preferably a disposable product intended for one completetreatment use. The housing and the valve member may be manufactured bymeans of molding, such as injection molding that is suitable for highproduction volumes to get the unit cost as low as possible. Morespecifically, the housing and the valve member may each be manufacturedin a single piece.

Terminology

As mentioned above, in the field of intravenous infusion where both aneutral fluid, such as a saline fluid, and one or more drug fluids areto be administered to a patient, the terminology normally used in theart is that the infusion of the neutral fluid is referred to as theprimary infusion or the main IV line, whereas the infusion of a drugfluids is referred to as the secondary infusion. This terminology willbe used in the present application. However, for the sake of clarity andexplanation, the more descriptive terms “saline”, “flushing” and “drug”will be used as equivalents to “primary” and “secondary” whereappropriate to designate parts of the primary and secondary infusion,different valve positions, different valve parts and different flowpaths.

The term “drug fluid” as used herein is to be interpreted in a widesense and should not be limited to pure drugs. Drug fluids may includevarious types of cytostatics which are to be infused into the vascularsystem of a patient intravenously in order to treat her/him from cancer.Other fluids which may be administered may include volume expanders,blood-based products, blood substitutes, medications, nutritionalsolutions, antibiotics etc.

The terms “flushing fluid” and “saline fluid” are used herein asequivalents. The terms are to be interpreted as comprising any suitablefluid to be administered to the patient and/or for priming/flushingpurposes. Especially, the flushing fluid may be a neutral fluid, such asa saline solution.

The term fluid passageway should be construed as including channels inthe form of a bore having defined end openings, open recessconfigurations, or combinations thereof.

The term “backpriming” as used herein is to be construed as an operationperformed for removing air from an infusion pathway, especially aninitially non-primed secondary line or drug line connected to a drugcontainer containing a drug fluid to be administered, said backprimingbeing performed by causing a flushing fluid to flow “backwards” or“upstream” into and fill the infusion pathway, thereby removing airthere from.

The term “flushing” as used herein is to be construed as the operationperformed for cleaning at least the valve or parts thereof frompreviously administered drugs, especially the main passageway of thevalve member.

Other features and advantages of embodiments of the present inventionwill become apparent to those skilled in the art upon review of thefollowing drawings, the detailed description, and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The inventive concept, some non-limiting embodiments and furtheradvantages of the inventive concept will now be further described withreference to the drawings.

FIG. 1A illustrates an embodiment of a valve shown from a firstperspective view.

FIG. 1B illustrates the embodiment of the valve of FIG. 1A shown from asecond perspective view.

FIG. 2A illustrates the embodiment of a housing shown from a firstperspective view.

FIG. 2B illustrates the embodiment of the housing of FIG. 2A shown froma second perspective view.

FIG. 2C illustrates the embodiment of the housing of FIG. 2A shown froma plan view.

FIG. 2D illustrates the embodiment of the housing of FIG. 2A shown insectional view taken substantially along the line A-A in FIG. 2C.

FIG. 3A illustrates a first embodiment of a valve member shown in frontelevation.

FIG. 3B illustrates a sectional view of the valve member shown in FIG.3A, taken substantially along the line A-A in FIG. 3A.

FIG. 3C illustrates a sectional view of the valve member shown in FIG.3A, taken substantially along the line B-B in FIG. 3A.

FIG. 3D illustrates a sectional view of the valve member shown in FIG.3A, taken substantially along the line C-C in FIG. 3A.

FIG. 3E illustrates a sectional view of the valve member shown in FIG.3A, taken substantially along the line D-D in FIG. 3A.

FIG. 3F illustrates a perspective view of the valve member shown in FIG.3A.

FIG. 4A illustrates a second embodiment of a valve member shown in frontelevational view.

FIG. 4B illustrates a sectional view of the valve member shown in FIG.4A, taken substantially along the line A-A in FIG. 4A.

FIG. 4C illustrates a sectional view of the valve member shown in FIG.4A, taken substantially along the line B-B in FIG. 4A.

FIG. 4D illustrates a sectional view of the valve member shown in FIG.4A, taken substantially along the line C-C in FIG. 4A.

FIG. 4E illustrates a sectional view of the valve member shown in FIG.4A taken substantially along the line D-D in FIG. 4A.

FIG. 4F illustrates a perspective view of the valve member shown in FIG.4A.

FIG. 5A illustrates the valve in a first drug position, indicating abackpriming flow path, shown from a perspective view.

FIG. 5B illustrates the valve of FIG. 5A shown in an elevational view.

FIG. 5C illustrates the valve of FIG. 5A shown in a plan view.

FIG. 5D illustrates the valve of FIG. 5A shown in a sectional view takensubstantially along the line B-B in FIG. 5B.

FIG. 5E illustrates the valve of FIG. 5A shown in a sectional view takensubstantially along the line A-A in FIG. 5C.

FIG. 5F illustrates the valve of FIG. 5A shown in a sectional view takensubstantially along the line C-C in FIG. 5B.

FIG. 6A illustrates a valve in the first drug position, indicating adrug flow path, shown from a perspective view.

FIG. 6B illustrates the valve of FIG. 6A shown in an elevational view.

FIG. 6C illustrates the valve of FIG. 6A shown in a plan view.

FIG. 6D illustrates the valve of FIG. 6A shown in a sectional view takensubstantially along the line B-B in FIG. 6B.

FIG. 6E illustrates the valve of FIG. 6A shown in a sectional view takensubstantially along the line A-A in FIG. 6C.

FIG. 6F illustrates the valve of FIG. 6A shown in a sectional view takensubstantially along the line C-C in FIG. 6B.

FIG. 7A illustrates a valve in the first drug position, indicating aflushing flow path, shown from a perspective view.

FIG. 7B illustrates the valve of FIG. 7A shown in an elevational view.

FIG. 7C illustrates the valve of FIG. 7A shown in a plan view.

FIG. 7D illustrates the valve of FIG. 7A shown in a sectional view takensubstantially along the line B-B in FIG. 7B.

FIG. 7E illustrates the valve of FIG. 7A shown in a sectional view takensubstantially along the line A-A in FIG. 7C.

FIG. 7F illustrates the valve of FIG. 7A shown in a sectional view takensubstantially along the line C-C in FIG. 7B.

FIG. 8A illustrates a valve in an optional flushing position, indicatinga flushing flow path, shown from a perspective view.

FIG. 8B illustrates the valve of FIG. 8A shown in an elevational view.

FIG. 8C illustrates the valve of FIG. 8A shown in a plan view.

FIG. 8D illustrates the valve of FIG. 8A shown in a sectional view takensubstantially along the line B-B in FIG. 8B.

FIG. 8E illustrates the valve of FIG. 8A shown in a sectional view takensubstantially along the line A-A in FIG. 8C.

FIG. 8F illustrates the valve of FIG. 8A shown in a sectional view takensubstantially along the line C-C in FIG. 8B.

FIG. 9A schematically illustrates a first flow path in the first drugposition.

FIG. 9B schematically illustrates a second flow path in the first drugposition.

FIG. 9C schematically illustrates a third flow path in the first drugposition.

FIG. 10A schematically illustrates a first flow path in a second drugposition.

FIG. 10B schematically illustrates a second flow path in a second drugposition.

FIG. 10C schematically illustrates a third flow path in a second drugposition.

FIG. 11A schematically illustrates IV infusion systems of U.S. typecomprising a valve according to an embodiment of the invention.

FIG. 11B schematically illustrates IV infusion systems of European typecomprising a valve according to an embodiment of the invention.

FIG. 12 schematically illustrates a known IV infusion system of U.S.type.

FIG. 13 schematically illustrates a known IV infusion system of Europeantype.

FIG. 14A is a flow chart illustrating a first alternative method ofusing a valve according of the invention.

FIG. 14B is a flow chart illustrating a second alternative method ofusing a valve according of the invention.

FIG. 14C is a flow chart illustrating a third alternative method ofusing a valve according of the invention.

FIG. 15A illustrates an alternative embodiment of a valve with analternative design of a distribution channel and provided with abifurcation structure, shown in plan view.

FIG. 15B illustrates a sectional view of the valve of FIG. 15A, in asection taken substantially along the line A-A in FIG. 15A.

FIG. 15C illustrates a perspective view of the valve of FIG. 15A.

FIG. 16A illustrates a housing comprised in the valve in FIG. 15A, shownin elevational view.

FIG. 16B illustrates the housing of FIG. 16A, shown in plan view.

FIG. 16C illustrates the housing of FIG. 16A, shown in perspective view.

FIG. 17A illustrates a valve member comprised in the valve in FIG. 15A,shown in elevational view.

FIG. 17B illustrates the valve member of FIG. 17A, shown in a sectionalview taken substantially along the line A-A in FIG. 17A.

FIG. 17C illustrates the valve member of FIG. 17A, shown in perspectiveview.

FIG. 18A illustrates an alternative embodiment of a valve member with arecess in the valve member where the back check valve may be fitted,shown in elevational view.

FIG. 18B illustrates the valve member of FIG. 18A, shown in sectionalview taken substantially along the line A-A in FIG. 18A.

FIG. 18C illustrates an alternative embodiment of a valve memberprovided with an integrated back check valve, shown in elevational view.

FIG. 18D illustrates the valve member of FIG. 18C, shown in sectionalview taken substantially along the line A-A in FIG. 18C.

FIG. 18E illustrates the valve member of FIG. 18A, shown in perspectiveview in a first condition before the back check valve is fitted.

FIG. 18F illustrates the valve member of FIG. 18C shown in a secondcondition with the back check valve fitted in place.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present inventive concept relates to disposable valves foradministration of drug fluids. For example, the drug fluids may includevarious types of cytostatics which are to be infused into the vascularsystem of a patient intravenously in order to treat her/him from cancer.Other fluids which may be administered by the present inventive valveinclude volume expanders, blood-based products, blood substitutes,medications, nutritional solutions, etc.

Valve Structure

With reference to the drawings, an embodiment of a 4-drug valve orstopcock 100 (FIG. 1A-FIG. 1B) for the administration of up to fourdifferent drug fluids is disclosed. While the disclosed embodimentcomprises four drug positions other embodiments may comprise a differentnumber of drug positions but more than one. Not all of the possible drugpositions of a given valve need to be used at each occasion. Forinstance, a 4-drug valve as disclosed may be used for administering twodrug fluids only.

The valve 100 comprises a cylindrical housing 200 (FIG. 2A-FIG. 2D) anda valve member 300 (FIG. 3A-FIG. 3F and FIG. 4A-FIG. 4F). Detailed viewsof the assembled valve 100 in different valve positions are shown inFIG. 5A to FIG. 7F.

A cylindrical body of the valve member 300 is rotatably arranged in acylindrical cavity 205 of the housing 200 in relation to a rotationalaxis 400. By cylindrical is here meant a cylinder shape with constantradius or cylindrical but possibly with a minor draft needed for theinjection mold production. The housing 200 and the valve member body mayhave shapes other than cylindrical. For example, they may be conical,including one or more frusto-conical parts.

In the assembled valve 100, an outer cylindrical surface 302 of thevalve member may be in sealing engagement with an inner cylindricalsurface 204 of the housing 200, thereby creating an assembly which isair tight and prevents the flow of fluids at those areas where thesurfaces are in sealing engagement. The diameter of the outer surface302 may be slightly larger than the inner surface 204 in order toprovide the sealed engagement.

Alternatively, other ways of providing the sealing engagement areconceivable. In some embodiments, one or more sealing elements (notshown) may be arranged between the housing 200 and the valve member 300.For example, a sealing element may be made of a thin, flexible materialwhich may be fitted snugly between the valve member and the housing. Forexample, a sealing member may be an O ring.

Reference numeral 207 indicates an inwardly directed flange or rim onthe inner surface of the housing 200. Reference numeral 307 indicates acorresponding annular recess in the valve element 300 for receiving theflange 207 in the assembled state in order to maintain the valve member300 in an axially fixed but still rotatable position in the housing 200.In an alternative embodiment FIG. 15A-FIG. 15C, the flange and theannular recess may be formed at the top part of the housing 200 and notat the bottom part. The recess and flange may also be constructed suchthat the valve member is provided with the flange and the house isprovided with the recess. The flange may also be annularly formed as aprotrusion.

The housing 200 and the valve member 300 may be fabricated in anymaterial which does not react chemically to any considerably extent withthe drug fluids to be used, and which thereby and also in other aspectsis suitable for medical applications. Moreover, the material must besuitable for sterile environments. Examples of materials include plasticmaterials. The plastic material may be transparent or opaque dependingon the medical application.

The housing 200 may be fabricated in the same material as the valvemember 300. Alternatively, the housing 200 may be fabricated in amaterial which is different from that of the valve member 300. Inparticular, the material of the housing 200 and the valve member mayhave different hardness. Different hardness may be used for providingtactile feedback during operation of the valve.

Different hardness and different material may also be used for providingimproved sealing engagement.

The housing 200 may comprise a housing wall 202 enclosing the innercylindrical cavity 205 into which the cylindrical valve member body isto be inserted. The cylindrical housing wall 202 may comprise an outercircumferential surface 206 and said inner cylindrical surface 204.

A valve according to the inventive concept may generally comprise aplurality of drug inlets D1, D2, etc. and a single flushing inlet F, allarranged at the outer housing surface 206. As disclosed in thisembodiment, a single flushing inlet F arranged on a first level L1 andthere may be four drug inlets D1 to D4 arranged on a second level L2with respect to the rotational axis axially below the flushing inletlevel L1.

Each one of the four drug inlets D1 to D4 is fluidly connected to anassociated drug outlet 208 which opens into the housing cavity 205. Eachdrug inlet D1 to D4 may be integrally formed with the cylindricalhousing wall 202 and shaped as a pipe or a stud. As in this embodiment,the four drug outlets 208 may be angularly spaced at 90 degrees aboutthe rotational axis 400.

The flushing inlet F may be arranged, in the circumferential direction,between two of the drug inlets and it opens into the inner housingcavity 205 at a separate flushing outlet 210. As for the drug inlets D1to D4, the flushing inlet F may be integrally formed with thecylindrical housing wall 202 and be shaped as a pipe or stud.

As disclosed in this embodiment, the single flushing outlet 210 on theone hand and the four drug outlets 208 on the other hand may be arrangedon different levels with respect to the rotational axis 400. In thedisclosed embodiment, the flushing outlet 210 is located on the firstlevel L1 and the drug outlets 208 are located on the second level L2different from the first level L1. The purpose of having the drugoutlets 208 arranged on a different level (L2) is to be able to haveaccess to the flushing fluid in each one of the plurality of drugpositions, as will be described in detail.

In the disclosed embodiment, the first level L1 is the upper level inthe drawings being located closer to a handle 304 of the valve member300 than the second level L2. It is possible to design the valve 100with the levels L1 and L2 being axially reversed.

As disclosed in the present embodiment, the flushing inlet F may bearranged on the first level L1 and the drug inlets D1 to D4 may bearranged on the second level L2, whereby associated passageways orchannels through the housing wall 202 would be radially oriented. Inother embodiments, the passageways through the housing wall 202 do nothave to be exactly radially oriented, allowing for different axialpositions of the flushing inlet F and the drug inlets D1 to D4 than thepositions shown in the drawings.

In general, a valve member of a valve according to the inventive conceptis arranged to be rotated into any selected one of a plurality of drugpositions. In the disclosed embodiment, there are four drug positions,each drug position being defined by the angular positions of anassociated drug outlet 208. Each drug position may be defined as a valveposition in which the inlet 322 of the main passageway 320 is alignedwith or registered with a drug outlet 208 associated with the drugposition.

The valve 100 comprises an outlet which is arranged to be connected to adownstream part of a primary IV line to be connected with a patient. Theoutlet of the valve 100 may be formed by the housing 200 or by the valvemember 300. In the present embodiment, the outlet is formed in thehousing 200. Specifically, the bottom part of the housing 200 mayinclude an outlet O which is fluidly connected to the inner cavity 205of the housing by means of a bottom channel 220 having a central bottomopening 222 positioned coaxially with the rotational axis 400. Thebottom channel 220 may compromise of two parts, including one part 220 aextending at least radially outwards from the rotational axis and onepart 220 b extending at least in the direction of the rotational axis400.

The housing 200 may be provided with a resilient lip 224, which in thisembodiment is integrally formed with the housing 200 at one side of thebottom opening 222 and which is arranged to cooperate with the valvemember 300 for providing a tactile response to the user indicatingdifferent valve positions. The construction of a tactical responsefunction may be achieved by a protrusion or a recess in the housing tointeract with the valve member.

In use, a neutral fluid, such as a saline solution, or equivalently asaline fluid, may be led into the flushing inlet F by means of anupstream part of a main IV line. This neutral fluid, termed “flushingfluid”, may comprise a sterile solution of sodium chloride (NaCl). Theflushing inlet F may be provided with a connection device (not shown)for connection with the flushing line or it may be glued to the flushingline. Connection devices may comprise male and female Luer connectors.Other connector types may be used.

The valve member 300 of the present embodiment will now be describedmore in detail with reference FIG. 3A to FIG. 4F illustrating a firstand a second embodiment, respectively, of the valve member 300.Identical reference numerals being used for identical or similar partsof the two embodiments.

A handle 304 integrally formed with the valve member body allows thevalve member 300 to be rotated by a user into different valve positions,especially into each one of the plurality of drug positions. In thisembodiment, the valve positions comprise at least the four drugpositions described above. The handle 304 may have a radial extensionallowing the user to identify a selected valve position. This isschematically illustrated in FIG. 8A to FIG. 9C for a first and a seconddrug position, respectively, in which drawings the handle 304 isdepicted as a thick bold line aligned with a selected one of the druginlets D1 to D4.

In the assembled valve, the resilient lip 224 at the housing bottom maybe operatively engaged with a contoured circumferential surface 310 of abottom groove 312 of the valve member 300 in order to provide a tactileresponse to the user when the valve member is rotated into a selectedvalve position.

In some embodiments, the contoured circumferential surface 310 and theresilient lip 224 may be formed as a protrusions, notches, grooves orrecesses with smooth or sharp edges to create a forced clockwiserotation, or a forced clock-wise rotation with a possibility to turn oneposition back from a flushing position to a previous drug position.

An object of the invention is to make it possible for the user, such asa nurse, to perform the administration of multiple drug fluids in asimple and safe manner. To this end, it may be preferred that the radialextension of the handle 304, in each selected drug position of the valvemember 300, is aligned with an associated drug inlet D1 to D4. Thetactile means described above may optionally be used to obtaining acorrect alignment of the valve member 300.

The cylindrical valve member body, being rotatably and sealinglyarranged in the housing cavity 205, is provided with a main fluidpassageway 320 having an inlet 322 arranged at the outer cylindricalvalve member surface 302 and an outlet 324 arranged coaxially with therotational axis 400 at the bottom 330 of the valve member 300. In apreferred embodiment as disclosed, the inlet 322 and the outlet 324constitute the only inlet and outlet, respectively, of the mainpassageway 320, in order to ensure a complete flushing thereof as willbe described below.

The main passageway 320 may be formed by a first part 320 a extendingfrom the inlet 322 of the main passageway 320 towards the rotationalaxis 400, and a second part 320 b extending coaxially with therotational axis 400 towards the outlet 324 of the main passageway 320.As disclosed, the main passageway 320 may be in the form of a closedtubular channel with the inlet 322 and outlet 324 in the form of definedopenings. The inlet opening 322, the tubular channel 320 and the outletopening 324 may all have the same or essentially the same cross sectionin order to obtain a laminar fluid flow through the main passageway. Theinlet opening 322 of the main passageway 320 and each one of the drugoutlets 208 of the housing 200 may have identical or matching crosssections which are mutually aligned in each selected drug position. Inother embodiments, the main passageway may be in the form of an openrecess or groove.

A feature of the valve 100 is that in each selected drug position, theflushing outlet 210 is fluidly connected to the drug outlet 208associated with the selected drug position. To this end, the valve 100is provided with a distribution of the flushing fluid in acircumferential direction with respect to the rotational axis 400.

In the disclosed embodiment, the circumferential distribution of theflushing fluid is accomplished by means of a circumferentially orienteddistribution channel 326, which is arranged on the first level L1 and isfluidly connected to the flushing outlet 210. Thus, in this embodiment,the flushing outlet 210 of the housing 200 opens into the distributionchannel 326.

In general, the distribution channel 326 will normally be formed in theinterface between the housing 200 and the valve member 300. In thedisclosed embodiment, the distribution channel 326 is formed by a groovein the valve member, said groove being radially closed by the innersurface 204 of the housing 200. It would also be possible to form thedistribution channel 326 by a combination of a stationary lower curvedsurface formed in the housing 200 and a rotatable upper curved surfaceformed in the valve member 300. Such an embodiment may be preferred ifthe valve should have the possibility of closed valve positionsmentioned earlier.

In the embodiment shown in FIG. 3A-FIG. 3F, the distribution channel 326extends in a circumferential direction less than 365 degrees to form apartial annular distribution channel having a first end 326A and asecond end 326B, wherein the valve member 300 presents a wall portion327 located circumferentially between the two ends 326A and 326B. Thewall portion 327 will move together with the valve member 300 in allrotational positions.

In an alternative embodiment, the wall portion 327 in the partly annulardistribution channel may be formed by the housing 200, and is in suchembodiments the wall portion is stationary for all rotary positions.

In the alternative embodiment shown in FIG. 4A-FIG. 4F, the distributionchannel 326 extends in a circumferential direction over 365 degrees toform a complete annular distribution channel.

The distribution channel 326 may also be formed at or on the bottom ofthe valve house when the valve house is constructed with a closed bottom230, as shown in FIG. 15A to FIG. 16C.

In the following, only the embodiment in FIG. 3A-FIG. 3F will bedescribed. As shown in FIG. 3A-FIG. 3F, the valve member 300 furthercomprises a transfer channel 328 for carrying the flushing fluid, thetransfer channel 328 being fluidly connected to the distribution channel326 and extending in the direction of the rotational axis 400 from thefirst level 1 to the second level L2. As best shown in the cross-sectionB-B in FIG. 3A-FIG. 3F, an upper inlet end of the axial transfer channel328 connects to the distribution channel 326 close to the end 326B ifthe wall portion 307 of the partly annular channel is formed by thevalve member 300. If the wall portion 207 of the partly annular channelis formed by the housing 200, the transfer channel connects to thedistribution channel close to the end 226B in one rotational position.Thereby, in the priming phase of the valve and when the transfer channelis positioned in relation to the flushing outlet 210 on the other sideof the wall portion 327, any air bubble residing in the distributionchannel 326 will be effectively pushed out from the distribution channel326 by the flushing fluid and into the transfer channel 328. Subsequentrotational positions may then have a primed distribution channel. Thus,the purpose of making the distribution channel only partly annularaccording to the embodiment in FIG. 3A-FIG. 3F is to prevent air bubblesin the distribution channel 326 and to create zero dead space within thevalve. This technique may optionally be used in other types ofmulti-drug valves also.

The lower end of the transfer channel 328 at the second level L2 isconnected to the main passageway 320 close to the inlet opening 322thereof. Accordingly, when rotating the valve member 300, the mainpassageway 320 and the transfer channel 328 rotates together with thevalve member 300 and are constantly in fluid connection with theflushing outlet 210 via the distribution channel 236.

Possible Flow Paths in a Selected Drug Position

Three different possible flow paths of the valve 100 in a drug positionwill now be described with reference to especially FIG. 5A-FIG. 7F whichshow the valve 100 in a first selected drug position of four possibledrug positions. In FIG. 5A-FIG. 7F, the flow path described is indicatedby a sequence of small unfilled circles for the neutral fluid and filledcircles for a drug fluid. In order to increase the understanding, FIG.9A-FIG. 9C illustrates in an very schematically way where each one ofthe three flow paths enters into and exits from the valve 100 in thefirst drug position. Corresponding flow paths for a second selected drugposition are schematically illustrated in FIG. 10A-FIG. 10C.

Backpriming Flow Path

FIG. 5A-FIG. 5F schematically illustrates a backpriming flow path FP ofa neutral flushing fluid through the valve 100 for performing abackpriming of a drug line (not shown), the drug line being connected atone end thereof to the first drug inlet D1. The backpriming flow path FPof the flushing fluid will be as follows in FIG. 5A-FIG. 5F:

-   -   Flushing inlet F fi Flushing outlet 210 on level L1 fi Into and        along distribution channel 326 to the inlet of transfer channel        328 fi Along transfer channel 328 to level L2 fi Into the main        passageway 320 close to the inlet 322 thereof fi “Backwards” out        through the drug outlet 208 associated with the first drug        position fi “Backwards” out through the drug inlet 210 fi        Backpriming of the drug line.

Drug Administering Flow Path

FIG. 6A-FIG. 6F schematically illustrates a drug flow path FP of a firstdrug fluid through the valve 100 for administering the first drug fluidto a patient, the drug fluid being contained in a drug containerconnected via drug line to the first drug inlet D1, and the outlet Obeing connected to a main IV line connected to a patient. The drug fluidflow path FP of the first drug fluid will be as follows in FIG. 6A-FIG.6F:

-   -   First drug inlet D1 fi Drug outlet 208 on level L2 fi Inlet 322        of the main passageway 320 fi Through the main passageway 320 to        the outlet 324 fi Outlet O.

Flushing Flow Path

FIG. 7A-FIG. 7F schematically illustrates a flushing flow path FP of aneutral flushing fluid through the valve 100 for performing a flushingof the valve 100 in order to remove residuals of the first drug fluidbefore administering a subsequent drug fluid. The flushing flow path FPof the flushing fluid will be as follows in FIG. 7A-FIG. 7F:

-   -   Flushing inlet F fi Flushing outlet 210 on level L1 fi Into and        along the distribution channel 326 to the inlet of the transfer        channel 328 fi Along the transfer channel 328 to level L2 fi        Into the main passageway 320 close to the inlet 322 thereof fi        Through and flushing the main passageway 320 to the outlet 324        fi Outlet O

It will be noted that the backpriming flow path in FIG. 5A-FIG. 5F andthe flushing flow path in FIG. 7A-FIG. 7F share the part of the flowpaths which extend from the flushing inlet F via the distributionchannel 326 to the outlet of the transfer channel 328. It will also benoted that the downstream part of the flushing flow path in FIG. 7A-FIG.7F covers or is common with the entire drug flow path inside the mainpassageway to flush the latter from drug residuals.

Flushing Flow Path in a Flushing Valve Position

The disclosed embodiment of the valve 100 may also be turned into anumber of “pure” flushing positions, in addition to the four drugpositions described above. FIG. 8A-FIG. 8F discloses the valve 100 wherethe valve member 300 is in such a “pure” flushing position. The flushingposition is in this embodiment a rotational position in-between two drugpositions. In a flushing position, the inlet 322 of the main passageway320 is closed by the inner surface 204 of the housing 200 and all drugoutlets 208 are closed by the outer surface 302 of the valve member 300.As a result, no drug fluid may enter the main passageway 320 in a “pure”flushing position. However, the flushing outlet 208 is still in fluidcontact with the main passageway 320 via the distribution channel 326and the transfer channel 328. Thereby, the flushing fluid may flowthrough the main passageway 320 and out of the outlet O as indicated inFIG. 8A-FIG. 8F.

IV Therapy System Provided with a Valve According to an Embodiment ofthe Invention

Reference is now made to FIG. 11A and FIG. 11B which schematicallyillustrate a “U.S. embodiment” 50 and a “European embodiment” 50′,respectively, of an IV therapy system including a valve 100 according toan embodiment of the invention.

Where appropriate, the same reference numerals as used for the prior-artsystems disclosed in FIGS. 12 and 13 are used also for the systems shownin FIG. 11A and FIG. 11B. The U.S. embodiment 50 in FIG. 11A wouldprobably be more suitable for use in the U.S. since a U.S. user thereofwould probably be familiar to a certain extent with the general sequenceof actions in using the system 50.

Each system 50 and 50′ in FIG. 11A and FIG. 11B comprises a valve 100according to an embodiment of the invention. The valve 100 is arrangedon a main IV line 16. In the U.S. system 50, the main drip chamber 14Ais located upstream of the valve 100 on the upper main line 16A and maybe integrated with a spike to connect to the container 12A. There mayalso be a back check valve 17A located upstream the valve 100 butdownstream the drip chamber 14A. A clamp to control flow rate, such as aroller clamp, may located downstream the valve 100. In an alternativesetup, a roller clamp may be used upstream the valve 100 to control theflow rate of the primary container alone. In yet another alternativeembodiment, there may be no clamps to control flow rate, and instead thesystem may include a slide clamp or a pinch clamp to fully open or fullyclose the fluid flow. Such an embodiment may be used when the flow rateis controlled by an infusion pump.

In the European system 50′, the main drip chamber 14A is locateddownstream of the valve 100 and the main line is connected to thecontainer 12A with a spike, a clamp is located upstream of the valve 100on the main line to control the primary fluid and is normally a fullyopen or a fully closed clamp, such as a slide clamp or a pinch clamp butmay be a roller clamp. A roller clamp may be provided downstream of thevalve 100 to control the flow rate. If the flow rate is controlled by aninfusion pump instead, this roller clamp may be replaced by a slideclamp or a pinch clamp to fully open or fully close the fluid flow.

A first drug IV set 16B and a second drug IV set 16C are connected to amain IV set 16 by means of the valve 100. The upstream line 16A of themain IV set 16 is connected to the flushing inlet F of the valve 100.The first and second drug IV sets 16B and 16C are connected to the firstdrug inlet D1 and the second drug inlet D2, respectively, of the valve100. A downstream part of the main IV set 16 is connected to thepatient, optionally via an infusion pump 30.

Infusion pumps may be used on the secondary lines 16B, 16C and/or on theupper main line 16A, to control the flow rate of each line individuallyin the U.S system setup as well as in the European system setup, when aback check valve 17A is used on the upper main line 16A.

Backpriming of the U.S. System

In using the U.S. system 50, backpriming of a (secondary) drug line ofeach drug IV set may be performed in the following sequence, describedfor the first drug IV set 16B as an example:

-   -   The first drug container 12B is spiked.    -   The first drug line 16B is then connected to the first drug        inlet D1 of the valve 100, optionally using a Luer connection.    -   The valve member 300 of the valve 300 is rotated by means of the        handle 304 into the first drug position (FIG. 5A to FIG. 7F)        such that the handle 304 is in a position where it is aligned        with or pointing over the first drug inlet D1 connected to the        drug line which is to be backprimed.    -   The clamp 18B on the drug line 16B is opened (if present).    -   The first drug container 12B is lowered to a level below the        flushing container 12A, thereby creating a hydrostatic pressure        difference to initiate the backpriming.    -   The secondary drug line 16B is then backprimed up to half the        volume in the drug drip chamber 14B.    -   When the backpriming of the drug line 16B is complete, the clamp        18B on the drug line 16B is closed and/or the container of the        back primed secondary line is held higher than the primary        container. As an alternative, the handle 304 is just rotated to        the next valve position to close off the secondary flow at the        first drug inlet D1.

Preparing the European System

In using the European system 50′, handling of the drug IV sets may beperformed in the following sequence, described for the first drug IV set16B as an example. It will be noted that in the European system 50′,there are normally no dripping chambers on the drug lines.

-   -   The first drug line 16B, which normally would be pre-filled with        a neutral solution, is connected to the first drug inlet D1 of        the valve 100, optionally using a Luer connection.    -   The flow of the first drug fluid B in the first drug line 16B is        closed. This may be done by using a clamp 18B on the first drug        line 16B. The flow of the first drug fluid B may also be closed        by the valve 100 by setting the valve handle into a different        position than the first drug position. A European drug line        would normally be equipped with a clamp.    -   The flushing container 12A should be shut off by the clamp 18A        located upstream the valve 100 on the main IV line 16A, if all        infusion bags 12A to 12C are located at the same head pressure.    -   This is in line with the procedure used today.

Operation of the Valve

In the two systems 50 and 50′ shown in FIG. 11A and FIG. 11B, the valve100 will operate as follows:

-   -   The flushing fluid A will flow to the patient from the flushing        container 12A when the handle 304 is positioned in a valve        position allowing fluid through the valve 100 from the flushing        inlet F to the outlet O. Such a position may be one of the drug        fluids described above. Such a valve position my optionally also        be a dedicated or “pure” flushing position (FIG. 8A-FIG. 8F).        The clamp 18A arranged on the downstream part of the main IV        line 16 will be open. If using the dedicated flushing position,        the valve 100 will ensure that no drug fluids B or C will flow        through the valve 100 to the outlet O.    -   A drug fluid B or C will flow when the handle 304 is located in        an associated drug position and when the clamp 18A located        downstream the valve 100 is opened, and the associated clamp        18B, 18C on the associated secondary line 16B, 16C is also        opened.    -   The flushing fluid A will not flow through the valve 100 when a        drug fluid, say drug fluid B, is flowing through the valve 100        to the outlet. In the U.S: system, the flushing fluid flow may        be prevented due to a pressure difference. The flushing fluid        flow may also be prevented by closing the main IV line 16A        upstream the valve 100 using a clamp 18A (if any).    -   In the U.S. system 50, when a drug IV set (16B, 16C) runs empty        during drug administering, the flushing fluid A will        automatically start flushing the main IV line 16A including the        valve 100. It will be noted that this is a specific advantage of        the valve, since the valve in each selected drug position also        provides fluid connection to the flushing fluid. For the        European system 50′, the clamp 18A on the main IV line 16A needs        to be opened before flushing is initiated.

FIG. 15A-FIG. 15C illustrates an alternative embodiment of a valve,where the transfer channel 328 and main channel inlet 322 bifurcates thedrug outlet 208 with a wall portion 332.

FIG. 16A-FIG. 16C illustrates a housing comprised in the valve in FIG.15A-FIG. 15C with a closed bottom 230 that forms a part of thedistribution channel 326

FIG. 17A-FIG. 17C illustrates a valve member compromised in the valveFIG. 15A-FIG. 15C with a transfer channel 328 and main channel 322 and awall section 332.

FIG. 18A-FIG. 18F illustrates an alternative embodiment including a backcheck valve 500 integrated in the transfer channel 328. The back checkvalve 500 as shown in FIG. 18C-FIG. 18D, and FIG. 18F is a small lipfitted into a recess 333 in the valve member 300 and it may be glued inplace and or be press fitted. The lip and the recess in the valve membermay be constructed such that the lip can deflect in one direction butnot in the other direction, in order to allow fluid to flow downstreambut not upstream in the transfer channel. The lip may be constructed ofa silicon or rubber material.

I claim:
 1. A valve for administering two or more drug fluids,comprising: a rotational axis, a housing having: an inner cavity aninner circumferential surface, one flushing inlet for receiving aflushing fluid, the flushing inlet being fluidly connected to a flushingoutlet, which opens into the inner cavity and is positioned on a firstlevel with respect to the rotational axis, and a plurality of druginlets, each drug inlet for receiving an associated drug fluid and eachdrug inlet being fluidly connected to an associated drug outlet openinginto the inner cavity and being positioned on a second level that isdifferent from the first level; and a valve member having: an outercircumferential surface, and a main passageway presenting an inletarranged in the outer circumferential surface at the second level and anoutlet arranged coaxially with the rotational axis; wherein the valvemember is arranged to be rotated into any selected one of a plurality ofdrug positions, each drug position being associated with a respectiveone of said drug outlets; and wherein, in each selected drug position,the drug outlet which is associated with the selected drug position isfluidly connected to both the inlet of the main passageway and to theflushing outlet.
 2. The valve according to claim 1, further comprising adistribution channel for carrying the flushing fluid, and formed at aninterface between the housing and the valve member, said distributionchannel being circumferentially oriented in relation to the rotationalaxis and fluidly connected to the flushing outlet; wherein the valvemember further comprises a transfer channel for carrying the flushingfluid, the transfer channel being fluidly connected to the distributionchannel and extending at least partly in the direction of the rotationalaxis towards the second level.
 3. The valve according to claim 2,wherein the transfer channel of the valve member is directly connectedwithin the valve member to the main passageway.
 4. The valve accordingto claim 2, wherein the housing further comprises a plurality offlushing recesses formed in the inner circumferential surface of thevalve housing, each flushing recess being associated with a selecteddrug position and extending at least partly in the direction of therotational axis and being fluidly connected to an associated drugoutlet; and wherein, in each selected drug position, the drug outletwhich is associated with the selected drug position is fluidly connectedto the flushing outlet via a flow path formed by the distributionchannel, the transfer channel and a flushing recess which is associatedwith the selected drug position.
 5. The valve according to claim 2,wherein the transfer channel has a first end, which is located on thefirst level and is fluidly connected to the distribution channel, and asecond end, which is located adjacent to the second level and whichtogether with the outlet of the main passageway, in each selected drugposition, bifurcates a drug outlet associated with the selected drugposition.
 6. The valve according to claim 2, wherein the distributionchannel extends in a circumferential direction over 365 degrees to forma complete annular distribution channel.
 7. The valve according to claim2, wherein the distribution channel extends in a circumferentialdirection less than 365 degrees to form a partial annular distributionchannel.
 8. The valve according to claim 1, wherein the valve member isfurther arranged to be positioned into any selected one of one or moreflushing positions; and wherein, in each selected flushing position, theinlet of the main passageway is fluidly connected to the flushing outletbut not to any one of the drug outlets.
 9. The valve according to claim1, wherein the inner circumferential surface of the housing is insealing engagement with the outer circumferential surface of the valvemember.
 10. The valve according to claim 1, wherein the innercircumferential surface of the housing and the outer circumferentialsurface of the valve member are cylindrical.
 11. The valve according toclaim 1, wherein the inner circumferential surface of the housing andthe outer circumferential surface of the valve member are conical orfrusto-conical.
 12. The valve according to claim 1, wherein the mainpassageway comprises a first part extending from the inlet of the mainpassageway towards the rotational axis, and a second part extendingcoaxially with the rotational axis, from an radially inner end of thefirst part of the main passageway, towards the outlet of the mainpassageway.
 13. The valve according to claim 1, wherein the plurality ofdrug positions constitute the only rotary positions of the valve memberallowing a drug to be administered from a drug inlet to an outlet of thevalve.
 14. The valve according to claim 1, wherein the valve member isprovided with a handle for rotating the valve member and wherein thefirst level is located closer to the handle than the second level. 15.The valve according to claim 1, wherein the valve member is providedwith a handle for rotating the valve member and wherein the second levelis located closer to the handle than the first level.
 16. The valveaccording to claim 1, wherein the valve member is provided with a handlefor rotating the valve member, wherein in each selected drug positionthe handle is aligned with a drug inlet associated with the selecteddrug position.
 17. A valve for administering two or more drug fluidscomprising: an outlet, a rotational axis, a housing having: an innercavity an inner circumferential surface, one flushing inlet forreceiving a flushing fluid, the flushing inlet being fluidly connectedto a flushing outlet, which opens into the inner cavity and ispositioned on a first level with respect to the rotational axis, and  aplurality of drug inlets, each drug inlet for receiving an associateddrug fluid and each drug inlet being fluidly connected to an associateddrug outlet opening into the inner cavity and being positioned on asecond level that is different from the first level; and a valve memberhaving: an outer circumferential surface, and a main passagewaypresenting an inlet arranged in the outer circumferential surface at thesecond level and an outlet arranged coaxially with the rotational axis;wherein the valve member is arranged to be rotated into any selected oneof a plurality of drug positions, each drug position being associatedwith a respective one of said drug outlets; and wherein the valvepresents, in each selected drug position: a drug flow path extendingfrom the associated drug outlet, through the main passageway, and to theoutlet of the valve, a flushing flow path extending from the flushingoutlet to the outlet of the valve and comprising a first part not beingcommon with the drug flow path and a second part being common with thedrug flow path, and a backpriming flow path extending from the flushingoutlet to the associated drug outlet and being at least partly commonwith the first part of the flushing flow path.
 18. A method foradministering a plurality of drug fluids to a patient using a flushingcontainer containing a flushing fluid, a plurality of drug containerseach containing an associated drug fluid and being provided with anassociated drug connector line, a valve having valve member which isarranged to be rotated into a plurality of drug positions, each drugposition for administering an associated drug fluid, and a primary IVline connected to a patient, said method comprising, for each drug fluidof said plurality of drug fluids: rotating the valve member into aselected drug position associated with the drug fluid; with the valvebeing in the selected drug position, backpriming a connector line of adrug container containing the drug fluid by providing a flow of theflushing fluid from the flushing container via the valve and into thesecondary connector line; thereafter, and with the valve being in theselected drug position, administering the drug fluid by providing a flowof the drug fluid from the drug container containing the drug fluid viathe valve to the primary IV line; and thereafter flushing the valve byproviding a flow of the flushing fluid from the flushing container viathe valve to the main IV line.
 19. The method according to claim 18,wherein, for each drug fluid of said plurality of drug fluids, theadministering of the drug fluid and the subsequent flushing of the valveis performed with the valve being in same selected drug position. 20.The method according to claim 18, wherein the backpriming is performedwhile keeping the flushing container at a higher level than a drugcontainer containing the selected drug fluid.
 21. The method accordingto claim 18, wherein the administering is performed while keeping a drugcontainer containing the selected drug fluid at a higher level than theflushing container.
 22. The method according to claim 18, wherein saidbackpriming, said administering and said flushing are performed insequence for one drug fluid at a time.
 23. The method according to claim18, wherein the backpriming is initially performed for all drug fluidsof said plurality of drug fluids before performing said administeringand said flushing for each drug fluid.